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Proffered paper and Mini oral mixed session on Head and neck

266O - Combination ipilimumab and nivolumab in recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): Updated efficacy and safety analysis of NCT03097939

Date

21 Nov 2020

Session

Proffered paper and Mini oral mixed session on Head and neck

Presenters

Hsiang-Fong Kao

Citation

Annals of Oncology (2020) 31 (suppl_6): S1347-S1354. 10.1016/annonc/annonc360

Authors

H. Kao1, M. Ang2, Q.S. Ng2, D.S.W. Tan2, W. Tan2, T. Rajasekaran2, A. Jain2, B. Liao1, S.H. Tan3, E. Tan2, N.G. Iyer4, M.L.K. Chua5, R. Hong1, D.W. Lim2

Author affiliations

  • 1 Medical Oncology, National Taiwan University Hospital, 10002 - New Taipei city/TW
  • 2 Division Of Medical Oncology, NCCS - National Cancer Centre Singapore, 169610 - Singapore/SG
  • 3 Division Of Clinical Trials And Epidemiological Sciences, National Cancer Centre Singapore, 169610 - Singapore/SG
  • 4 Division Of Surgical Oncology, NCCS - National Cancer Centre Singapore, 169610 - Singapore/SG
  • 5 Division Of Radiation Oncology, NCCS - National Cancer Centre Singapore, 169610 - Singapore/SG
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Resources

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Abstract 266O

Background

Nasopharyngeal cancer (NPC) is common in Southeast Asia and Southern China. It is infiltrated by T-regulatory cells and shows high expression of PD-L1. However, monotherapy PD-1/PD-L1 activity is limited and not superior to salvage combination chemotherapy. We hypothesized that CTLA-4 blockade would suppress T-regulatory function and complement PD-1 blockade. We update the efficacy and safety from the first phase II study of this combination in NPC.

Methods

A single arm phase II of a Simon 2-stage design was used, with preplanned expansion for safety and efficacy. Pts were treated with Nivolumab 3 mg/kg q2 weeks, and Ipilimumab 1 mg/kg q6 weeks. Eligible pts had R/M NPC, measurable plasma EBV DNA, no more than 1 prior line of chemotherapy, ECOG 0-1, and adequate organ function. All pts who met the eligibility criteria and received at least one dose of the combination drugs were included in the safety and efficacy analysis. The primary efficacy endpoint was best overall response (BOR) by RECIST 1.1. Toxicity was assessed using CTCAE criteria.

Results

Forty pts were enrolled between July 2017 and September 2019 across Taiwan and Singapore (data cut-off February 2020). Median age was 53 years (23-73 years). Most (90.0%) were of Chinese ethnicity and 33 (82.5%) were male. Thirty-nine pts (97.5%) had prior chemotherapy treatment. Six (15%) pts remain on study. The median number of cycles received was 4. Overall, 12 pts had a BOR of PR (30%; 95% CI 16.6%-46.5%). The median duration of response (DOR) was 5.9 months (95% CI 3.95-8.97 months). With a median follow up of 17.3 months, median PFS was 5.3 months (95% CI 3.0-6.4 months) and median OS was 17.6 months (95% CI 13.1-30.0). Thirty-four pts (85%) experienced treatment-related (Tr) events. Common TrAEs included maculopapular rash (n=16; 40%) and hypothyroidism (n=11; 28%). Four (10%) pts experienced Grade 3/4 TrSAEs including hypocortisolism, pneumonia, myasthenia gravis, and raised lipase. There was no relationship of tumor mutation burden/PD-1 expression to response.

Conclusions

Combination Nivolumab/Ipilimumab is active and safe in NPC, with durable responses and PFS, presenting a possible alternative to salvage chemotherapy.

Clinical trial identification

NCT03097939.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Bristol-Myers Squibb; Ono pharmaceuticals.

Disclosure

All authors have declared no conflicts of interest.

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